Coronavirus (COVID-19) Update: Daily Roundup August 20, 2020

FDA News Release

• For Immediate Release: August 20, 2020

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• The FDA has released a temporary industry guidance entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers.” The FDA recognizes the COVID-19 pandemic is not only impacting public health, but also drug development programs, ongoing manufacturing operations and the FDA’s ability to conduct inspections. The questions and answers in the guidance provide information regarding inspections for facilities that manufacture pharmaceutical products and sites involved in the conduct of clinical, analytical and nonclinical studies.
• As part of the FDA’s effort to protect consumers, the agency issued a joint warning letter with the Federal Trade Commission to Living Senior, LLC for selling fraudulent COVID-19 related products. Living Senior, LLC, sells cannabidiol (CBD) products with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Currently, there are no FDA-approved products to prevent or treat COVID-19. FDA has requested that Living Senior, LLC, immediately stop selling these unapproved and unauthorized products. Consumers concerned about COVID-19 should consult with their health care provider.
• The FDA has issued a warning letter to Predictive Biotech, Inc., for marketing CoreCyte, an unapproved umbilical cord-derived product claiming to mitigate, prevent, treat diagnose and/or cure COVID-19. Additionally, the FDA, in conjunction with the Federal Trade Commission, issued a separate letter to PA Green Wellness, LLC, for offering CoreCyte for sale to patients in the U.S. to prevent COVID-19.
• FDA, in partnership with OSHA, developed the Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic. The checklist will assist the food industry with operational changes it may have as a result of COVID-19. The checklist pulls guidance from the FDA, CDC, and OSHA; and serves as a quick reference in the areas of employee health, social distancing, and food safety for food operations that have been impacted during the pandemic.
• Testing updates:
  • To date, the FDA has currently authorized 218 tests under EUAs; these include 176 molecular tests, 39 antibody tests, and 3 antigen tests.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.